Data / Medical devices / South Korea / META SYSTEMS CO., LTD also doing business as S-Denti Co.,Ltd
META SYSTEMS CO., LTD also doing business as S-Denti Co.,Ltd: FDA-registered device maker in Seongnam-si Gyeonggi, South Korea, 4 510(k) clearances
META SYSTEMS CO., LTD also doing business as S-Denti Co.,Ltd is registered with the FDA (registration 3007663058) in Seongnam-si Gyeonggi, South Korea. It lists 7 device types. The FDA files 4 510(k) clearances under its listings, the newest dated October 14, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3007663058
- Address
- #1214-18, Sicox tower 12F, 484, Dunchon-daero Jungwon-gu, Seongnam-si Gyeonggi, South Korea, 13229
- Owner or operator
- Meta Biomed, Inc (10029431)
- Roles
- Manufacturer
- First device listed
- September 14, 2012
- Registered through
- 2026
- Brand names listed
- EQ Condenser, EQ-M, EQ-PEX, EQ-S, EQ-V, GUTTA PERCHA CARTRIDGE, LHALA JET, i-ROOT 100 mini
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Activator, Ultraviolet, For Polymerization | EBZ | 2 | Manufacturer | accessdata.fda.gov |
| Brush, Dermabrasion, Powered | GFE | 1 | Manufacturer | accessdata.fda.gov |
| Gutta-Percha | EKM | 1 | Manufacturer | accessdata.fda.gov |
| Handpiece, Direct Drive, Ac-Powered | EKX | 1 | Manufacturer | accessdata.fda.gov |
| Locator, Root Apex | LQY | U | Manufacturer | accessdata.fda.gov |
| Pick, Massaging | JET | 1 | Manufacturer | accessdata.fda.gov |
| Plugger, Root Canal, Endodontic | EKR | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 14, 2025 | K253461 | Demi Pro | EBZ | Substantially Equivalent | Meta Systems Co., Ltd. | accessdata.fda.gov |
| September 21, 2022 | K210475 | EQ-M | EKX | Substantially Equivalent | Meta Systems Co., Ltd. | accessdata.fda.gov |
| October 20, 2021 | K210789 | EQ-PEX | LQY | Substantially Equivalent | Meta Systems Co., Ltd. | accessdata.fda.gov |
| April 26, 2012 | K112153 | IROOT 100 MINI | LQY | Substantially Equivalent | S-Denti Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Gutta-Percha
- All makers of Pick, Massaging
- All makers of Handpiece, Direct Drive, Ac-Powered
- All makers of Locator, Root Apex
- All makers of Brush, Dermabrasion, Powered
- All makers of Activator, Ultraviolet, For Polymerization
Updated October 14, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.